Heart Valve Repair Devices for Placement in Ventricle and Delivery Systems for Implanting Heart Valve Repair Devices

ABSTRACT

Devices and methods for the repair of the functioning of heart valves are provided. A device may comprise a ventricular winding having a generally spiral shape, wherein the device is free of any atrial stabilizing section. A method involves positioning the device such that chords associated with the heart valve are positioned within the path of the generally spiral shape of the ventricular winding and turning the ventricular winding such that the chords move closer to the center of the ventricular winding. The ventricular winding draws the chords closer together, thereby pulling the valve leaflets closer together in order to facilitate their coaptation and proper closing. A delivery system for maneuvering and releasing a heart valve repair device comprises an applicator tube and internal rod.

FIELD OF THE INVENTION

The invention relates to devices and methods for the repair of thefunctioning of heart valves, in particular the mitral valve.

BACKGROUND OF THE INVENTION

Heart valves regulate the movement of blood into and out of the chambersof the heart. The mitral valve, positioned between the left atrium andthe left ventricle, can be subject to a condition known as mitralregurgitation, in which the mitral valve does not close properly andsome backflow of blood occurs from the left ventricle back into the leftatrium. For example, a mitral valve leaflet can experience prolapseduring systole, thereby inhibiting leaflet coaptation and permittingbackflow of blood into the left atrium.

Various procedures and devices have been proposed to address thecondition of mitral regurgitation. For example, some mitral valve repairprocedures involve removing a section of a valve leaflet in order toreduce its propensity for prolapse. Other procedures involve mitralvalve replacement. The MITRACLIP (Abbott Vascular) is a device intendedto be positioned across the mitral valve to create a double orifice, inan effort to allow the valve to close fully during systole.

US 2010/0331971 discloses cardiac valve downsizing devices and methods.

The objective of these downsizing devices is to downsize the annulus ofthe valve by circumflexing all or substantially all of the chords. Adownsizing device as disclosed in US 2010/0331971 is formed as a helixwherein a lower part of the helix is designed to extend on theventricular side of the valve along an outer periphery adjacent theheart wall around the outermost chords. This outer periphery is accessedby extending the helix through a commissure at the periphery of thevalve or through the annulus itself. Rotating the helix causesadvancement of the helix so that part of the helix extends into theventricle at the outer periphery around the outermost chords, while partof the helix is in the atrium, adjacent the annulus, thereby anchoringthe device with respect to the atrium.

The Applicant's prior application US 2013/0006352 also relates todevices and methods for the repair of the functioning of heart valves.US 2013/0006352 discloses heart valve repair devices designed to drawthe desired leaflet edge areas together. A device as disclosed in US2013/0006352 comprises a first section having a generally spiral shape,with the spiral shape emanating from a center of the spiral, and asecond section connected to the first section at the center of the firstsection. The first section is positioned on the ventricular side of theheart valve, with the selected chords positioned within the path of thegenerally spiral shape, and the second section is positioned on theatrial side of the heart valve. US 2013/0006352 discloses that, in adevice as described therein, the ventricular section draws the capturedchords together, thereby pulling the desired valve leaflet areastogether, while the atrial section stabilizes or anchors the devicerelative to the atrium.

There is a continuing need for improved treatment for mitral valveregurgitation and for the repair of the functioning of heart valves ingeneral. The various procedures and devices previously proposed can beimproved upon in terms of their overall clinical outcome, ease of use,reduction of procedure time and risk, and/or reduction of cost.

SUMMARY OF THE INVENTION

The present invention provides devices and methods for the repair of thefunctioning of heart valves.

In prior heart valve repair devices for capturing leaflet chords asexemplified in certain prior devices as discussed above, the deviceshave included parts or sections for anchoring the devices relative tothe atrium, in order to ensure that the devices remained stable in theheart once implanted. The inventive heart valve repair devices asdescribed herein depart from these prior teachings. A heart valve repairdevice as described herein comprises a ventricular winding for capturingleaflet chords and drawing them together, without having any connectedatrial stabilizing section that stabilizes or anchors the devicerelative to the atrium. The device, without any atrial stabilizingsection, has freedom to move with respect to the atrium, providingpreviously unrecognized advantages as described below that could not beattained by prior devices that were anchored to the atrium. While priordevices as discussed above have included atrial anchoring in order toensure stability after implantation, the inventors have found, in bothex vivo testing and in vivo animal testing, that a device as describedherein with a ventricular winding and without a connected atrialstabilizing section is sufficiently held in place by the interactionbetween the ventricular winding and the chords, thereby allowing thedevice to be practiced without a connected atrial stabilizing section,realizing advantages as described herein.

In some embodiments, the implantable heart valve repair devicecomprises, consists essentially of, or consists of a ventricular windinghaving a generally spiral shape adapted to be positioned on aventricular side of the heart valve such that chords associated with theheart valve are positioned within the path of the generally spiral shapeof the ventricular winding. The ventricular winding is designed to drawchords associated with the heart valve closer together, thereby pullingthe valve leaflets closer together in order to facilitate theircoaptation and proper closing. The implantable heart valve repair devicein these embodiments is “free of any atrial stabilizing section,”meaning that the device does not have any part that is adapted tostabilize the device by engaging tissue on the atrial side of the valve,such as the wall of the atrium or the annulus of the valve on the atrialside.

In some embodiments, the implantable heart valve repair device has astabilizing section that consists only of a ventricular stabilizingsection that is adapted to engage tissue only on the ventricular side ofthe valve. The ventricular stabilizing section may consist essentiallyof, or consist only of, or may be in the form of a ventricular windinghaving a generally spiral shape as described above for drawing chordsassociated with the heart valve together. The ventricular winding isadapted to engage tissue only on the ventricular side of the valve, andthe ventricular winding stabilizes the device by the interaction betweenthe ventricular winding and the chords on the ventricular side of thevalve.

In some embodiments, the implantable heart valve repair device mayinclude a grasping element for facilitating grasping and maneuvering thedevice during implantation. In some embodiments, the implantable heartvalve repair device may include an end portion that is bent downwardlyfrom the general plane of the ventricular winding. In some embodiments,the implantable heart valve repair device may include one or moreanti-rotation elements for resisting a backwards rotation of theventricular winding.

In some embodiments of a method of repairing a heart valve, a heartvalve repair device is delivered to the area of the heart valve, whereinthe device comprises, consists essentially of, or consists of aventricular winding having a generally spiral shape.

The method further includes positioning the ventricular winding on aventricular side of the heart valve such that chords associated with theheart valve are positioned within the path of the generally spiral shapeof the ventricular winding. The step of positioning the ventricularwinding may further include turning the ventricular winding in a firstdirection such that the chords move closer to the center of theventricular winding. This movement of the chords pulls the valveleaflets closer together in order to facilitate their coaptation andproper closing. The method may be practiced with a heart valve repairdevice that is free of any atrial stabilizing section, as describedabove.

In some embodiments of a delivery system for implanting a heart valverepair device, the delivery system comprises an applicator tube and aninternal rod within the applicator tube. The internal rod may be adaptedto hold the heart valve repair device during maneuvering of the device.The delivery system is adapted to release the heart valve repair deviceafter positioning of the heart valve repair device in the desiredlocation. The delivery system may include a window through which all orpart of the heart valve repair device may be ejected. The deliverysystem may also include a ramp surface for facilitating ejection of theheart valve repair device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a perspective view of an embodiment of a heart valve repairdevice.

FIG. 2 shows a side view of another embodiment of a heart valve repairdevice.

FIG. 3 shows a side view of another embodiment of a heart valve repairdevice.

FIG. 4 shows a top view of another embodiment of a heart valve repairdevice.

FIGS. 5A-5C show alternative versions of heart valve repair devices withanti-rotation elements.

FIG. 6 illustrates a proximal end of a delivery system for implanting aheart valve repair device.

FIG. 7A shows a top view of a distal end of the delivery system of FIG.6.

FIG. 7B shows a side view of a distal end of the delivery system of FIG.6.

FIG. 8 shows a perspective view of the distal end of the delivery systemof FIG. 6 with a heart valve repair device being held by the deliverysystem.

FIG. 9 shows a perspective view of the distal end of the delivery systemof FIG. 6 with a heart valve repair device being ejected from thedelivery system.

FIG. 10 shows a retention wire threaded through a grasping element of aheart valve repair device.

FIG. 11 shows another embodiment of a delivery system hook and graspingelement.

FIG. 12 shows a top view diagram of leaflets of a mitral valve.

DETAILED DESCRIPTION

The Applicant's prior application US 2013/0006352 discloses variousheart valve repair devices and methods of implanting them. Thedisclosure of US 2013/0006352 is hereby expressly incorporated herein byreference.

Certain embodiments of heart valve repair devices and methods of usingthem are described herein with reference to the accompanying drawings.These embodiments are only examples, as numerous variations of theinvention disclosed herein are possible within the scope of the appendedclaims.

FIG. 1 shows a first embodiment of a heart valve assisting device 110.The device 110 comprises a ventricular winding 112 and a graspingelement 120. As described below, the ventricular winding 112 serves thefunctions of both facilitating valve leaflet coaptation and stabilizingor anchoring the device with respect to the chords.

The term “spiral” is used herein to refer broadly to shapes defined by astructure forming a winding around a center wherein the windinggradually moves away from the center as it winds around the center. Thestructure of the winding may begin or emanate from an area at or nearthe center of the winding. The winding may move away from the center ata constant rate or at a non-constant rate, and the general outline ofthe spiral may take various shapes, such as substantially circular,substantially elliptical, or other shapes. The spiral may be symmetricalor asymmetrical, and the center around which the winding structure windsmay be a point at the geometric center of the spiral or a point that isoffset from the geometric center of the spiral. The winding may be inone plane, such that the spiral is substantially flat. Alternatively,the winding may not be in one plane, with the winding moving up or downat a constant or non-constant rate. Thus, for example, the spiral may besubstantially conical. The winding may make multiple turns around thecenter or less than a full turn around the center. The winding structureof the spiral forms a path that starts from an opening at the outerperiphery of the spiral and that moves toward the center of the spiralas the path winds around the center of the spiral.

As can be seen in FIG. 1, the ventricular winding 112 has a generallyspiral shape. The spiral shape is defined by the wire structure of theventricular winding 112 forming a winding around a center 114 of theventricular winding 112, wherein the wire structure of the windingbegins or emanates from an area at or near the center 114 and graduallymoves away from the center 114 as it winds around the center 114. In thecase of FIG. 1, the winding of the ventricular winding 112 moves awayfrom the center 114 at a generally constant rate, and the generaloutline of the spiral of the ventricular winding 112 has a substantiallycircular shape.

In the embodiment of FIG. 1, the ventricular winding 112 is generally inone plane, with an end portion 124 of the ventricular winding 112 beingbent or angled downwardly as shown. In an alternative embodiment, theventricular winding 112 may move gradually out of plane.

As shown in FIG. 1, the winding structure of the ventricular winding 112forms a path 118 that starts from an opening 116 at the outer peripheryof the spiral and that moves toward the center 114 of the spiral as thepath 118 winds around the center 114 of the spiral. In this illustratedembodiment, the path 118 comprises about three turns around the center114. More or fewer turns may be used.

As described above, the spiral may take other shapes. In addition, theventricular winding may be comprised of more than one spiral. Forexample, the ventricular winding may have two, three, four, or morespirals, which may be similar or dissimilar to each other. In oneexample, two spirals may emanate from a common center, each beingsimilar to the other except that each starts in a direction that is 180degrees from the other. This example results in nested spirals in whichthe opening of each of the spirals is 180 degrees from the opening ofthe other spiral. In other examples, three spirals may emanate from acommon center, starting 120 degrees apart and having openings 120degrees apart, or four spirals may emanate from a common center,starting 90 degrees apart and having openings 90 degrees apart.

The overall diameter D1 of the ventricular winding may be substantiallysmaller than the diameter of the annulus of the valve. This enablesmaneuvering the ventricular winding to capture only selected groups ofchords, in order to pull together desired areas of the valve leaflets.For example, the overall diameter D1 of the ventricular winding 112 maybe approximately 1.0-2.0 centimeters (e.g., 1.2, 1.5, or 1.8centimeters), but larger or smaller diameters are possible.

At its outer end, the ventricular winding 112 terminates at the endportion 124. In the embodiment of FIG. 1, the end portion 124 is bentdownwardly from the general plane of the ventricular winding 112. Theend portion 124 is formed as a loop of the wire structure of theventricular winding 112, connected at junction 126. In this manner, theend portion 124 terminates at a rounded atraumatic tip 125.

In this embodiment, the length of the end portion 124 is approximately 5mm, and it may have other lengths, such as 8 mm, or longer or shorterlengths. The end portion 124 in this embodiment bends downwardly fromthe general plane of the ventricular winding 112 by an angle ofapproximately 15 degrees, and it may bend at other angles, such as 25degrees, or larger or smaller angles. In this embodiment, the designresults in a gap in the axial direction between the general plane of theventricular winding 112 and the tip 125 of the end portion 124 ofapproximately 1 mm to 5 mm, but larger or smaller gaps are possible.

The grasping element 120 is connected to the center 114 of theventricular winding 112 and extends upwardly from the center 114 of theventricular winding 112.

As shown in FIG. 1, the grasping element 120 is formed of a continuationof the wire structure of the ventricular winding 112. The wire structureforming the grasping element 120 extends upwardly from the general planeof the ventricular winding 112 at an angle of approximately 90 degrees,although other angles may be used. After extending upwardly from theventricular winding 112, the wire structure of the grasping element 120bends at a top bend 121 and extends downwardly to an end 122 of the wirestructure, thereby forming a loop. The top bend 121 forms an atraumatictip, and the end 122 may be blunt or rounded or may form a junction withthe adjacent portion of the wire structure, similar to the junction 126.In alternative embodiments, the grasping element 120 may besubstantially straight, curved, bent, helical, or any other suitableshape. In one example, the length of the grasping element 120 (from theconnection with the ventricular winding 112 to its top at bend 121) maybe approximately 5 mm to 20 mm, for example 6 mm to 8 mm or 10 mm, butlonger or shorter lengths are possible.

As can be seen in FIG. 1, the implantable heart valve repair device 110is free of any atrial stabilizing section, i.e., the device does nothave any part that is adapted to stabilize the device by engaging tissueon the atrial side of the valve, such as the wall of the atrium or theannulus of the valve on the atrial side. It is possible, for example,that after implantation the grasping element 120 extends through thevalve to the atrial side, and it may contact the leaflets as they close.However, neither the grasping element 120 nor any other part of thedevice 110 is adapted to engage tissue on the atrial side of the valvein a manner that stabilizes or anchors the device with respect to theatrium.

The device 110, including the ventricular winding 112 and the graspingelement 120, is comprised of a wire. In alternative embodiments, all orpart of the device may comprise a wire, a bundle of wires, a strip, arod, or a tube, and different sections of the device or parts thereofmay comprise a wire, a bundle of wires, a strip, a rod, a tube, or acombination thereof. The structure may be formed by bending or otherwiseshaping a wire, a bundle of wires, a strip, a rod, or a tube into thedesired shape. The desired shape may be obtained by “baking” thematerial in a certain shape at a certain temperature such that thematerial will remember that shape. Alternatively, the shape may beformed as the wire, bundle of wires, strip, rod, or tube is formed. Forexample, the spiral shape of the ventricular winding may be chemicallyor laser etched or otherwise cut from a sheet of material, in which casethe strip or rod is formed simultaneously with the spiral shape. Thedevice may be formed of more than a single structure or material; forexample, a tube with a wire core may form the ventricular winding and/orthe grasping element, with the other element formed of a similar ordissimilar structural component.

The use of a bundle of wires can provide the device with high axialstrength as well as high flexibility. For example, the use of severalthin wires in a twisted bundle or in a braided bundle provides highaxial strength and flexibility that can be determined by the twisting orbraiding structure.

The wire, bundle of wires, strip, rod or tube may have any suitablecross-sectional shape. For example, the wire, bundle of wires, strip,rod or tube may have a circular, elliptical, square, rectangular,hexagonal, or other cross-sectional shape. The wire, bundle of wires,strip, rod, or tube may have different cross-sectional shapes or sizesat different places along its length. The wire of device 110 has acircular cross-sectional shape along its length. In one example, thewire, bundle of wires, strip, rod, or tube may have a diameter, width orthickness of approximately 0.2-1.0 millimeters (e.g., 0.4 millimeters),but larger or smaller dimensions are possible.

The wire of device 110 is formed from a suitable shape memory metal, forexample nitinol. Other suitable materials may be used for all or part ofthe wire(s), rod(s), or tube(s) of the device, for example other shapememory materials, other metallic materials, plastic materials and/orcomposite materials.

The device 110 of FIG. 1 has rounded ends 121, 125 at the ends of thegrasping element 120 and end portion 124. In alternative embodiments,one or more ends of the wire, bundle of wires, strip, rod, or tube maybe rounded, squared-off, or pointed. As described further below, thedevice may have one or more anti-rotation elements.

As can be seen in FIG. 1, the spiral of ventricular winding 112 can beconsidered as being wound in a clockwise direction when viewed from thetop and starting from the center and moving outward. In an alternativeembodiment, the spiral of the ventricular winding 112 can be wound in anopposite direction.

The wire, bundle of wires, strip, rod, or tube may have one or moregrooves in its outer surface. The groove in the outer surface of thewire, bundle of wires, strip, rod, or tube may extend around theperimeter of the wire, bundle of wires, strip, rod, or tube and/or inthe direction of the length of the wire, bundle of wires, strip, rod, ortube. As one example, the wire, bundle of wires, strip, rod, or tube mayhave one more grooves that extend in a substantially helical path alongthe wire, bundle of wires, strip, rod, or tube. Such grooves may servedifferent purposes. For example, one or more grooves may be used tocreate different flexibilities at different places of the device, tofacilitate ingrowth of tissue, to facilitate grasping and manipulation(e.g., pushing, pulling, turning, etc.) of the device, and/or aschannels for drug delivery. For example, a helical groove can be used tofacilitate rotation of the device as it is being delivered from orwithdrawn into a delivery catheter. Similarly, a helical or other groovecan direct cell growth in layers in a preferred direction, therebyreducing scar formation.

The wire, bundle of wires, strip, rod, or tube may have one or moreholes in it. The holes may be through-holes extending all the waythrough the thickness of the wire, bundle of wires, strip, rod, or tube,and/or the holes may be pockets or dimples in the outer surface of thewire, bundle of wires, strip, rod, or tube. The holes may be a series ofholes extending along the length and around the periphery of the wire,bundle of wires, strip, rod, or tube. The holes may serve differentpurposes. For example, one or more holes may be used to create differentflexibilities at different places of the device, to facilitate ingrowthof tissue, to facilitate grasping and manipulation of the device, toprovide ports for injection of a contrast agent, and/or as sites fordrug delivery.

The device may comprise a coating on the wire, bundle of wires, strip,rod, or tube. The coating is preferably a biocompatible coating that maybe used, for example, to reduce possible negative reactions from thetissue where the device is implanted, to reduce friction (as alubricious coating) to assist in delivery of the device, to reducefriction in areas where the device is designed to be moved againsttissue (for example, along the path of the spiral of the ventricularwinding), to increase friction in areas where it is desired to reducemovement or to anchor the device, to deliver a suitable drug, forradiopacity, to encourage cell and tissue growth that would assist infixation (e.g., of the upper section), to encourage tissue growthbetween the chords and/or leaflets, and/or for other purposes. Withrespect to radiopacity, the entire device or selected points on thedevice may be coated or plated with a material allowing the physician tounderstand the location of the device during and/or after theimplantation procedure. For example, the ends of the spiral may beplated with a radiopaque material. If selected points on the device areplated, the plating at the selected points may have a certain shape(e.g., a line, arrow, etc.) to assist in understanding the orientationof the device. In another example, in the case of a device formed of atube, the tube may be coated to ensure that the coated tube is sealed inorder that the tube may be used, for example, for pressure measurement.When the coating is a drug-release coating, the coating may comprise acarrier (for example, a polymer) with the drug in the carrier for drugelution over a suitable period of time. The drug eluting mechanism mayuse a biodegradable carrier (e.g., a biodegradable polymer) or a stablecarrier (e.g., a stable polymer) that allows the drug elution throughdiffusion of drug molecules.

FIG. 2 shows another embodiment of a heart valve repair device 130. Thedevice 130 comprises a ventricular winding 132 and a grasping element140. The ventricular winding 132 has a generally spiral shape, definedby the wire structure of the ventricular winding 132 forming a windingaround a center 134 of the ventricular winding 132. The wire structureof the winding emanates from the center 134 and gradually moves awayfrom the center 134 as it winds around the center 134. In the case ofdevice 130, the winding of the ventricular winding 132 moves outwardfrom the center 134 at a generally constant rate, thereby forming asubstantially circular shape (in top view), while at the same time thewinding moves upward from its starting point at the center 134, therebyforming a substantially conical helix opening upward, with the base ofthe cone above the vertex. In an alternative embodiment, the winding ofthe ventricular winding moves outward from its starting point at thecenter while at the same time moving downward from its starting point atthe center, thereby forming a substantially conical helix openingdownward, with the base of the cone below the vertex. As shown in FIG.2, the ventricular winding 132 terminates at its outer periphery at anatraumatic end portion 144, which is bent downwardly, similar to endportion 124.

In the device 130, like the device 110, the winding structure of theventricular winding 132 forms a path that starts from an opening at theouter periphery of the spiral and that moves toward the center 134 ofthe spiral as the path winds around the center 134 of the spiral.

The device 130, like the device 110, may be comprised of a wire having acircular cross-section. The wire of device 130 may be formed of asuitable shape memory metal, for example nitinol.

The grasping element 140 of device 130 is similar in construction to thegrasping element 120 of device 110. As can be seen in FIG. 2, the device130 is free of any atrial stabilizing section.

As would be understood by persons of ordinary skill in the art from theabove descriptions, alternative embodiments of the device 130 may beformed, using the variations described above with respect to the device110. Thus, for example, the ventricular winding 132 and the graspingelement 140 may comprise other forms, shapes, sizes and/or materials asdescribed above with respect to the device 110. The ends of the devicemay be rounded, squared-off, or pointed. The device 130 may have one ormore anti-rotation elements, as described further below. The ventricularwinding 132 and/or the grasping element 140 may have one or more groovesand/or holes, as described above. The device may comprise a coating, asdescribed above.

FIG. 3 shows another embodiment of a heart valve repair device 150. Thedevice 150 comprises a ventricular winding 152 and a grasping element160. The ventricular winding 152 has a generally spiral shape, definedby the wire structure of the ventricular winding 152 forming a windingaround a center 154 of the ventricular winding 152. The wire structureof the winding emanates from the center 154 and gradually moves awayfrom the center 154 as it winds around the center 154. In the case ofdevice 150, in an inner section 151, the winding of the ventricularwinding 152 moves outward from the center 154 at a generally constantrate, thereby forming a substantially circular shape (in top view),while at the same time the winding moves upward from its starting pointat the center 154, thereby forming a substantially conical helix openingupward, with the base of the cone above the vertex. Then, the innersection 151 transitions to an outer section 153, in which the winding ofthe ventricular winding 152 stays substantially in a single plane as itmoves outward from the center 154 at a generally constant rate. In analternative embodiment, the inner section may stay substantially in asingle plane with the outer section forming a section of a substantiallyconical helix. As shown in FIG. 3, the ventricular winding 152terminates at its outer periphery at an atraumatic end portion 164,which is bent downwardly, similar to end portion 124.

In the device 150, like the device 110, the winding structure of theventricular winding 152 forms a path that starts from an opening at theouter periphery of the spiral and that moves toward the center 154 ofthe spiral as the path winds around the center 154 of the spiral.

The device 150, like the device 110, may be comprised of a wire having acircular cross-section. The wire of device 150 may be formed of asuitable shape memory metal, for example nitinol.

The grasping element 160 of device 150 is similar in construction to thegrasping element 120 of device 110. As can be seen in FIG. 3, the device150 is free of any atrial stabilizing section.

As would be understood by persons of ordinary skill in the art from theabove descriptions, alternative embodiments of the device 150 may beformed, using the variations described above with respect to the device110. Thus, for example, the ventricular winding 152 and the graspingelement 160 may comprise other forms, shapes, sizes and/or materials asdescribed above with respect to the device 110. The ends of the devicemay be rounded, squared-off, or pointed. The device 150 may have one ormore anti-rotation elements, as described further below. The ventricularwinding 152 and/or the grasping element 160 may have one or more groovesand/or holes, as described above. The device may comprise a coating, asdescribed above.

FIG. 4 shows another embodiment of a heart valve repair device 170. Thedevice 170 comprises a ventricular winding 172 and a grasping element180. The ventricular winding 172 has a generally spiral shape, definedby the wire structure of the ventricular winding 172 forming a windingaround a center 174 of the ventricular winding 172. The wire structureof the winding emanates from the center 174 and gradually moves awayfrom the center 174 as it winds around the center 174. In the case ofdevice 170, the winding of the ventricular winding 172 moves outwardfrom the center 174 at an uneven rate. Thus, the gap between adjacentturns of the winding is non-constant, as can be seen by a comparisonbetween smaller inner gap 172A and larger outer gap 172B. As shown inFIG. 4, the ventricular winding 172 terminates at its outer periphery atan atraumatic end portion 184.

In the device 170, like the device 110, the winding structure of theventricular winding 172 forms a path that starts from an opening at theouter periphery of the spiral and that moves toward the center 174 ofthe spiral as the path winds around the center 174 of the spiral.

The device 170, like the device 110, may be comprised of a wire having acircular cross-section. The wire of device 170 may be formed of asuitable shape memory metal, for example nitinol.

The grasping element 180 of device 170 may be similar in construction tothe grasping element 120 of device 110 or may be generally in the sameplane as the ventricular winding 172. As can be seen in FIG. 4, thedevice 170 is free of any atrial stabilizing section.

As would be understood by persons of ordinary skill in the art from theabove descriptions, alternative embodiments of the device 170 may beformed, using the variations described above with respect to the device110. Thus, for example, the ventricular winding 172 and the graspingelement 180 may comprise other forms, shapes, sizes and/or materials asdescribed above with respect to the device 110. The ends of the devicemay be rounded, squared-off, or pointed. The device 170 may have one ormore anti-rotation elements, as described further below. The ventricularwinding 172 and/or the grasping element 180 may have one or more groovesand/or holes, as described above. The device may comprise a coating, asdescribed above.

As mentioned above, the implantable heart valve repair devices 130, 150,and 170, like the heart valve repair device 110 and other heart valverepair devices described herein, are free of any atrial stabilizingsection. Each of the implantable heart valve repair devices 110, 130,150, and 170 has a stabilizing section that consists only of aventricular stabilizing section in the form of a ventricular winding112, 132, 152, and 172, which is adapted to engage tissue only on theventricular side of the valve and to stabilize the device by theinteraction between the ventricular winding 112, 132, 152, and 172 andthe chords on the ventricular side of the valve. In some embodiments,these heart valve repair devices also may be described as not having anypart that, after implantation, contacts tissue in the atrium or on theatrial side of the valve and/or not having any part that, afterimplantation, extends into the atrium or on the atrial side of thevalve. However, as described above, it is possible in some embodimentsfor the grasping element to extend through the valve to the atrial side,and it may contact the leaflets. However, these embodiments may beconstructed such that neither the grasping element nor any other part ofthe device is adapted to engage tissue on the atrial side of the valvein a manner that stabilizes or anchors the device with respect to theatrium.

FIGS. 5A-5C illustrate examples of anti-rotation elements that may beused with a heart valve repair device, including any of the heart valverepair devices described herein. FIG. 5A shows a heart valve repairdevice 190 having an anti-rotation element 191 in the form of aprotrusion on the end of the ventricular winding. FIG. 5B shows a heartvalve repair device 192 having an anti-rotation element 193 in the formof an enlarged tooth on the end of the ventricular winding. FIG. 5Cshows a heart valve repair device 194 having an anti-rotation element195 in the form of an enlarged area on an inner turn of the winding,coming close to or touching an adjacent turn. The anti-rotation elementscan help prevent backward rotation of the device after implantation, byallowing easier rotation of the device in the direction of bringing thechords together than in the opposite direction. Thus, for example, atooth having a slanted front face (on the side facing the outer openingof the path of the spiral) and steep back face can permit rotation ofthe device in the direction that brings the leaflets together (by thechords passing over the slanted front face) and can help resist rotationin the opposite direction (by the chords acting against steep back face,thereby resisting backward rotation).

In the example of one or more protrusions 191 as shown in FIG. 5A, theforce applied by the delivery system during the process of turning thedevice 190 to capture the chords can result in the wire structureflexing sufficiently to create a large enough gap between the protrusion191 and the adjacent turn of the winding in order to allow the chords topass therethrough, so that the device 190 may be wound around thechords. Similarly, in the example of one or more protrusions 193 asshown in FIG. 5B, the force applied by the delivery system during theprocess of turning the device 192 to capture the chords can result inthe wire structure flexing sufficiently to create a large enough gapbetween the tooth 193 and the adjacent turn of the winding in order toallow the chords to pass therethrough, so that the device 192 may bewound around the chords. Similarly, in the example of one or moreenlarged areas 195 as shown in FIG. 5C, the force applied by thedelivery system during the process of turning the device 194 to capturethe chords can result in the wire structure flexing sufficiently tocreate a large enough gap between the enlarged area 195 and the adjacentturn of the winding in order to allow the chords to pass therethrough,so that the device 194 may be wound around the chords. In each of theseexamples, the geometry of the anti-rotation element(s) helps prevent thedevice from unintentionally rotating in the opposite direction.

FIG. 6 illustrates a proximal end of a delivery system of a type thatmay be used for implanting a heart valve repair device, such as any ofthe heart valve repair devices described herein. The delivery system 300includes a flexible applicator 400, which is generally tubular in shape,and an internal rod 450, which is moveable within the applicator 400. Anapplicator gripper 310 may be used to help push, withdraw, and rotatethe applicator 400, in both clockwise and counterclockwise directions.An applicator irrigation port 320 allows injecting irrigation fluidsinto the applicator 400. An internal rod torquer 330 may be used torotate the internal rod 450 within the applicator 400. An internal rodgrip 340 is connected to the internal rod 450 and may be used to controlmovements of the internal rod 450, including pushing it forward in orderto eject a hook that is connected to internal rod 450, as describedbelow. A scale or ruler 350 facilitates measuring how far the internalrod 450 has been advanced, so as to determine the position of the hookinside the applicator 400. A safety plate 360 prevents inadvertentadvancement of the internal rod grip 340, in order to eliminate thepossibility of accidentally pushing the hook outside of the applicator400.

FIGS. 7A and 7B show top and side views, respectively, of a distal endof the delivery system 300, with a heart valve repair device 110 loadedon the delivery system 300. In these figures, it can be seen that theflexible applicator 400 has lateral slots 402 to facilitate bending.Other manners of imparting flexibility to a catheter may be used,including selection of appropriate flexible material(s). The applicator400 has a rounded, atraumatic distal end 404. The applicator 400 has awindow 410 through which all or part of the heart valve repair devicemay be ejected. A ramp surface 420 adjacent the distal end of the window410 facilitates ejection of the device, as described below.

The internal rod 450 terminates in a hook 460. The hook 460 is designedto hold the grasping element of the heart valve repair device while thehook 460 is inside the applicator 400, proximal to the window 410.

In a first example implantation, the delivery system 300 holds a heartvalve repair device 110 as shown in FIGS. 7A and 7B, with theventricular winding 112 positioned outside of the lumen of theapplicator 400 and with the grasping element 120 positioned inside thelumen of the applicator 400 and held by the hook 460. In this position,the internal wall of the lumen of the applicator 400 prevents thegrasping element 120 from exiting the hook 460. Thus, as long as thehook 460 is inside the lumen of the applicator 400 (and not in thewindow 410), the grasping element 120 remains hooked on the internal rod450 and is thereby locked to the internal rod 450.

The delivery system 300 is used in conjunction with a catheter tube, forexample a steerable catheter as is known in the art. One example of asteerable catheter is the AGILIS catheter of St. Jude Medical, Inc. Thecatheter is sized to accommodate the applicator 400 of the deliverysystem 300. For example, if the applicator 400 has a size of 7.5 French,the outer catheter may have a size of 12 French. This is just anexample, as other sizes may be used.

In this first example, with the ventricular winding 112 positionedoutside of the lumen of the applicator 400, the distal end of theapplicator 400 is advanced into the proximal end of the steerablecatheter. Because the lumen of the steerable catheter is only slightlylarger than the outer diameter of the applicator 400, and smaller thanthe outer periphery of the ventricular winding 112, as the applicator400 is further advanced into the catheter, an internal turn of theventricular winding 112 comes into contact with the edge of the cathetertube at its proximal end. Further advancement of the applicator 400 intothe catheter will thereby cause the ventricular winding 112 to unwindand straighten as it is advanced into the catheter along with theapplicator 400. It will be appreciated that the center part of theventricular winding 112 will be advanced into the catheter first, andthe ventricular winding 112 will unwind from the center to the outerperiphery as the ventricular winding 112 is advanced into the catheter.When fully advanced into the catheter, the generally unwound ventricularwinding 112 is held in a relatively straightened position between theouter wall of the applicator 400 and the inner wall of the catheterlumen. The applicator 400 may be advanced into the catheter eitherbefore or after the catheter is tracked to the patient's heart.

The catheter is positioned adjacent the heart valve to be treated, forexample a mitral valve, by a method known in the art. The approach maybe, for example, a transseptal approach, with the catheter entering theleft atrium through the septum between the right atrium and the leftatrium. To facilitate a transseptal approach, the delivery system mayinclude an atrial septum dilator. Other approaches alternatively may beused, including, for example, a transfemoral approach through thefemoral artery and through the aorta and into the left ventricle, atransapical approach through the heart wall at the heart apex into theleft ventricle, or a transatrial approach through the heart wall intothe left atrium. Similarly, when the valve to be treated is thetricuspid valve, the catheter is positioned adjacent the valve by amethod known in the art (such as being introduced to the heart via ajugular vein or the vena cava).

Once the guide catheter is adjacent the heart valve, the tip of theguide catheter may be moved and/or turned so that it is facing the heartvalve leaflets. The applicator 400 then may be advanced relative to thecatheter, thereby ejecting the ventricular winding 112 from thecatheter. Because of the shape memory of the ventricular winding 112,the heart valve repair device 110 returns to a position as shown inFIGS. 7A and 7B, inside the heart. The ejection of the ventricularwinding 112 from the catheter may be performed in the atrium.Alternatively, the ejection of the ventricular winding 112 from thecatheter may be performed in the ventricle. If ejected in the atrium,the delivery system 300 then may be used to advance the distal end ofthe applicator 400, and with it the ventricular winding 112, into theventricle. The distal end of the applicator 400 and the ventricularwinding 112 may be pushed through the valve into the ventricle.

FIG. 8 shows a perspective view of the distal end of the delivery system300, with the ventricular winding 112 ejected from the guide catheterand outside of the tube of the applicator 400, and with the graspingelement 120 still inside the tube of the applicator 400 and connected tothe hook 460. In this position, rotation of the applicator 400 causesthe heart valve repair device 110 to be rotated along with it. Duringrotation of the applicator 400, the action of the frame of the window410 against the device 110 causes the device 110 to rotate with theapplicator 400. Additionally or alternatively, the hook 460 or anotherpart of the delivery system 300 may sufficiently hold the device 110 tocause the device 110 to rotate. Due to the geometry of the device, theaxis of the delivery system can be generally aligned with the axis ofrotation of the ventricular winding.

In the condition as shown in FIG. 8, and with the ventricular winding112 positioned in the ventricle, the delivery system may be used tocapture the desired chords with the ventricular winding 112. Thephysician may maneuver the ventricular winding 112 from side to side tocapture specific chords in order to bring desired areas of the leafletstogether. For example, by suitably moving and turning the ventricularwinding 112, the chords associated with the leaflet areas A1 and P1(FIG. 12) may be captured. Additionally or alternatively, the chordsassociated with the leaflet areas A2 and P2 and/or A3 and P3 (FIG. 12)may be captured.

In this manner, the desired chords associated with the anteriorpapillary muscle and the desired chords associated with the posteriorpapillary muscle are positioned within the path 118 of the generallyspiral shape of the ventricular winding 112. By turning the ventricularwinding 112, whether by turning the applicator 400 or by anothersuitable mechanism, the ventricular winding 112 is thereby turned towind around the selected anterior and posterior chords. As theventricular winding 112 is turned, the spiral shape forces the chordswithin the path 118 closer to the center 114 of the ventricular winding112. In this manner, the captured anterior chords and posterior chordsare forced closer together, thereby reducing a gap between the selectedchords associated with the anterior papillary muscle and the selectedchords associated with the posterior papillary muscle. By doing this,because the selected chords are attached to the selected areas of theleaflets, the selected areas of the leaflets are brought closertogether.

In order that the ventricular winding may be turned to move the chordsin this manner and may hold the chords, the heart valve repair device,or at least the ventricular winding, should have sufficient stiffnesssuch that the spiral shape is generally maintained. Thus, the deviceshould be sufficiently rigid so as to maintain the spiral shape on itsown and under the forces applied to it by the chords.

In alternative embodiments in which the ventricular winding comprisesmore than one spiral, the device may be formed so that it can gather andmove the chords with fewer rotations. Thus, for example, with theventricular winding comprising multiple spirals and with the openingsfor the spirals positioned at different places around the perimeter ofthe ventricular winding, chords at different places around the perimeterof the ventricular winding may be gathered simultaneously and movedtoward the center simultaneously.

In order to adjust the device, after the physician has turned theventricular winding 112 in a first direction as described above, thephysician may turn the ventricular winding 112 back in the oppositedirection in order to allow the chords to move apart by some amount.Thus, in this example, after the positioning resulting from clockwiseturning, the physician may turn the ventricular winding 112counterclockwise (when viewed from the top) in order to allow thecaptured chords to move away from the center 114 of the ventricularwinding 112, thereby allowing them to separate by some distance. Thephysician can monitor the positioning of the chords and leaflets andturn the ventricular winding 112 clockwise or counterclockwise as neededin order to obtain the desired result.

If desired, after the ventricular winding 112 has been rotated into thedesired rotational position, the physician may pull the ventricularwinding 112 to bring it closer to the heart valve. This may beaccomplished by retracting the applicator 400.

When the ventricular winding 112 is in the desired position, theremainder of the device 110 is ejected from the applicator 400, as shownin FIG. 9. With the applicator 400 held relatively stable, the internalrod 450 is advanced distally within the applicator 400. This moves thehook 460 to be located at the window 410. During this distaladvancement, the grasping element 120 is advanced distally against theramp surface 420, which forces the grasping element 120 away from theapplicator 400 and the hook 460. With the hook 460 in the window 410,the grasping element 120 is no longer prevented from exiting the hook460 by the internal wall of the lumen of the applicator 400. Thegrasping element 120 is released from the hook 460, and the device 110is left in place. The delivery device 300 is then withdrawn from thepatient. This leaves the heart valve repair device 110 implanted in thepatient.

If the procedure is one in which the valve is approached from the atriumas described above, once the device is implanted in the ventricle, thegrasping element will be pointing generally toward the atrium. If, onthe other hand, the procedure is one in which the valve is approachedfrom the ventricle, once the device is implanted in the ventricle, thegrasping element will be pointing generally away from the atrium andgenerally toward the apex of the heart.

Other heart valve repair devices as described herein, such as the heartvalve repair devices 130, 150, 170, and 190, and the variationsdescribed above with respect to the heart valve repair devices 110, 130,150, 170, and 190, may be implanted in a similar manner as describedabove.

The inventive heart valve repair devices as described herein providecertain advantages with respect to prior devices. As discussed above, inprior heart valve repair devices for capturing leaflet chords asexemplified in certain prior devices, the devices have included parts orsections for anchoring the devices relative to the atrium, in order toensure that the devices remained stable in the heart after implantation.By contrast, the inventive heart valve repair devices 110, 130, 150,170, and 190, and the variations described above with respect to thesedevices, depart from these prior teachings and are free of any atrialstabilizing section. The inventors have found that not only is itpossible to implant the inventive heart valve repair devices and havethem remain stable in the heart after implantation despite the absenceof any atrial stabilizing section, but the inventors also have foundthat the inventive heart valve repair devices provide previouslyunrecognized advantages that could not be attained by prior devices thatwere anchored to the atrium.

As the heart pumps, the various parts of the heart are in motion. Thechords connecting the papillary muscles to the leaflets are in motion. Aheart valve repair device as described herein without any atrialstabilizing section is free to move along with the chords, while at thesame time retaining the chords in their drawn-in condition for leafletcoaptation. Over time, tissue may grow around the ventricular windingsuch that the ventricular winding becomes substantially embedded in thechords. This tissue enveloping of the device results in a fixation ofthe device to the chords.

In prior devices that have included atrial stabilizing sections, thedevices have been anchored relative to the atrium. However, during thebeating of the heart and the opening and closing of the valves, thechords move relative to the atrium. Thus, when such a prior device isimplanted and anchored to the atrium, the chord movement relative to theatrium results in chord movement relative to the device. A deviceanchored to the atrium is constrained from moving freely with thechords. This constraint can occur at the time of the implantationprocedure and longer. When a device is constrained in this manner, thechords can rub relative to such a device, which can cause irritation,injury, and/or rupture of the chords.

By contrast, a heart valve repair device as described herein, withoutany atrial stabilizing section, can be affixed only to the chords. Thus,the device is free to move along with the chords, such as in anup-and-down direction generally in the direction of the axis ofimplantation, while at the same time maintaining the chords in theirdrawn-in condition for leaflet coaptation. This movement of the devicecan occur relative to the atrium. Thus, by being free of any atrialstabilizing section, the device has the previously unrealized advantagesof reducing or eliminating the potential for chord movement relative tothe device and reducing or eliminating the consequent potential forirritation, injury, and/or rupture of the chords that can be caused bysuch relative movement.

While prior devices as discussed above have included atrial anchoring inorder to ensure stability after implantation, the inventors have foundthat a device as described herein, in both ex vivo testing and in vivoanimal testing, is stable in the heart after implantation, despite nothaving an atrial stabilizing section. The device is sufficiently held inplace by the interaction between the ventricular winding and the chords.Accordingly, the inventors have found that it is possible to realize theadvantages as described herein and have the device be stable in theheart after implantation, without the need for a connected atrialstabilizing section as in the prior devices discussed above.

The use of a device without any atrial stabilizing section can haveseveral additional advantages. For example, by not having an atrialstabilizing section, the device can be smaller, simpler and lessexpensive to manufacture, easier to implant, more maneuverable tofacilitate targeted treatment, less prone to tissue injury, and mayimprove overall outcome.

The presence of an atrial stabilizing section can result in a relativelylarger or longer device, requiring positioning the device on the atrialside as well as on the ventricular side of the valve. Thus, the devicewithout any atrial stabilizing section can lead to easier implantation.Implantation is also facilitated because the device is easier tovisualize without any atrial stabilizing section.

Without an atrial stabilizing section, it can be easier to maneuver therelatively small ventricular winding to capture specific groups ofchords. The presence of an atrial stabilizing section can limit therange of placement of the device. That is, a relatively large atrialstabilizing section can limit the side-to-side range of the device,potentially limiting the areas in which the device can be placed, andlimiting the groups of chords that can be captured. By contrast, thesmaller, more maneuverable device leads to an improved ability toaddress specific chords and/or specific areas of a valve.

The device without an atrial stabilizing section also reduces the chanceof tissue injury on the atrial side of the valve, which can occur due tothe engagement of tissue on the atrial side. Such engagement can occurduring the delivery procedure or after implantation.

A person of ordinary skill in the art will understand that the variousheart valve repair devices described herein may be implanted accordingto the method described above. Various features of the device canfacilitate the procedure and functioning.

For example, the grasping element allows the device to be held by thedelivery system, so that it can be held, maneuvered, turned, andreleased as described above. Because the grasping element can extendfrom at or near the center of the ventricular winding, the device can beturned by simply rotating the ventricular winding generally around theaxis of the grasping element. When the device is fully deployed, thegrasping element may be located fully within the ventricle or may extendinto the atrium.

The end portion of the ventricular winding, bent away from the generalplane of the winding, can facilitate capturing of the chords. Thedistance of the end portion away from the general plane of the windingcan determine the span of the potential chords to be grasped. Therounded atraumatic tip of the end portion can help prevent injury to thechords, leaflets, and/or other tissue.

When all or part of the ventricular winding is out of plane, such as ina conical or partially-conical embodiment as shown in FIGS. 2 and 3, theheight dimension of the ventricular winding can help maintain thevertical positioning of the device within the ventricle. The heightdimension also allows more contact with the chords in the verticaldirection. This can reduce the friction between the device and thechords and can increase tissue coverage of the device. In addition, theheight dimension can allow easier visualization of the device.

When the spacing of the turns of the ventricular winding is largertoward the outer periphery, as shown in FIG. 4, the design canfacilitate capturing the chords (by the larger outer spacing) while alsobringing them close together (by the narrower inner spacing).

The device can have anti-rotation elements that can help prevent theventricular winding from turning backward (in the loosening direction)after implantation. Thus, the ventricular winding can have one or moreanti-rotation elements 191, 193, 195, as shown in FIGS. 5A-5C, that helpkeep the device in place. Other mechanisms for resisting unwindinginclude the use of different shapes. For example, if the ventricularspiral is in an elliptical shape, the chords will tend to gather in theapices of the long axis of the ellipse. In order for the device torotate, the chords would need to be drawn closer together, which is amovement they would tend to resist. Accordingly, such an ellipticalshape can assist in preventing an unwanted rotation of the device.

It will be appreciated that in procedures in which the delivery systemapproaches the heart valve from the ventricular side (e.g., intransfemoral and transapical approaches), similar methods to thosedescribed above may be used, modified to account for the fact that thedelivery system approaches the valve from the opposite side.

The delivery system may have means for retrieving and/or moving theheart valve repair device after it has been partially or fully deployed.For example, FIG. 10 shows a retraction wire 500 that may be placedinside the grasping element 121 of the heart valve repair device. Theretraction wire 500 can be located inside the applicator 400, but canalso remain inside the grasping element 121 after the heart valve repairdevice has been ejected from the applicator 400. Pulling the retractionwire 500 can withdraw the heart valve repair device back, so that it canbe moved to a different position or fully removed from the patient.

FIG. 11 illustrates an alternate form of a hook 470 used to engage arelatively flat grasping element 472. As can be seen, in this embodimentthe grasping element 472 is generally in the same plane as theventricular winding. In this embodiment, the device is released simplyby turning the hook 470 relative to the grasping element 472, such thatthe hook 470 can be withdrawn from the grasping element 472.

While the above method has been described with respect to a device inwhich the ventricular winding is positioned outside of the applicatorfor delivery, as in FIG. 8, variations are possible. For example, theventricular winding may be positioned inside of the applicator 400,whereby it is held in a relatively straightened position. Fordeployment, the device is ejected from the applicator, at which time theventricular winding resumes its spiral shape.

As would be understood from the above descriptions by persons ofordinary skill in the art, alternative embodiments of the devices 110,130, 150, 170, and/or 190 may be implanted generally as described above.The method of implantation may be varied as appropriate with respect tothe particular embodiment used and the particular patient being treated.

When a device as described is placed in position as described, thespiral of the ventricular winding reduces a gap between selected chordsassociated with the anterior papillary muscle and selected chordsassociated with the posterior papillary muscle. In this manner, theselected areas of the leaflets of the valve are drawn closer together.In some instances, the control of the chords also can reduce themovement of the leaflets, in order to help prevent prolapse. The controlof the chords and the drawing of the leaflets closer together facilitatecoaptation of the leaflets, such that they can close togethersufficiently to correct the regurgitation issue. The device can be leftin place as a long-term treatment.

FIG. 12 shows a top view of leaflets of a mitral valve. A device asdescribed herein may be used in various positions and for gatheringvarious chords. For example, the device may be positioned approximatelyin the area of A2 and P2 near the center of the anterior and posteriorleaflets. The chords on A2 and P2 are trapped and gathered by thespiral(s) of the ventricular winding. A rotation of the spiral wouldeventually bring all such chords to the same location, which is thespiral center. In this situation, the gap between A2 and P2 could bebrought to zero. Rotating the spiral a little less would result in anarrow gap. The device alternatively may be positioned approximately inthe area of A1 and P1, in which case the chords on A1 and P1 are trappedand gathered by the spiral(s) of the ventricular winding, reducing thedistance between A1 and P1. The device alternatively may be positionedapproximately in the area of A3 and P3, in which case the chords on A3and P3 are trapped and gathered by the spiral(s) of the ventricularwinding, reducing the distance between A3 and P3. A device with a largespiral positioned approximately in the area of A2 and P2 may trap andgather chords on A2, P2, A1, P1, A3 and/or P3, and can be used to reducethe distance between P1 and P3, for example, or A1 and A3.

With a relatively small heart valve repair device as described herein,for example having a ventricular winding with an outside diameter of1.0-2.0 centimeters, for example, it is possible to capture less thansubstantially all of the chords and to capture small groups of chords.Implanting such a device may involve positioning the spiral of theventricular winding between chords rather than around substantially allof the chords. Also, with a relatively small heart valve repair deviceas described herein, it is possible to implant multiple devices,capturing different sets of chords. The flow through the valve can beadjusted by selectively adjusting the different devices. For example,one device could be placed capturing the chords on A1 and P1, a seconddevice could be placed capturing the chords on A2 and P2, and a thirddevice could be placed capturing the chords on A3 and P3. The flow canbe evaluated, and if necessary, adjusted. For example, the device at A1and P1 could be rotated to bring the associated chords closer together,while the device at A3 and P3 could be rotated in an opposite direction.

In some instances, it may be desired to use the device to draw theleaflets closer and then position a clip anchored to both leaflets orstitch or suture the leaflets together. Thus, the device in conjunctionwith one or more clips, stitches or sutures can facilitate coaptation ofthe leaflets.

If desired, the device may be adjusted or withdrawn at a later time,either shortly or long after the implantation. A catheter may be used toaccess the device. To adjust the device, the physician may turn thespiral of the ventricular winding as described above (e.g., by turningthe device) in order to bring the chords closer together or to allowthem to separate further apart, as desired. Thus, the turning may bedone while performing the initial implantation procedure and/or as anadditional later procedure that is separate from the implantationprocedure. In this manner, the regurgitation grade can be controlled.Alternatively, if it is desired to withdraw the device altogether, agrasping mechanism may be used to grasp the device and pull it back intothe catheter, in essentially the reverse of the procedure that was usedto deliver the device.

Numerous alternatives are possible within the scope of the invention.For example, as mentioned above, the winding of the spiral may move awayfrom the center at a non-constant rate. Thus, the spiral density neednot be constant.

If the device is formed as a tube, a wire or stiffening element may beplaced into the tube in order to change the stiffness and/or shape ofthe tube or a section of it. For example, a stiffening element may beused to maintain the device in a first shape for delivery (e.g.,relatively straight), and the stiffening element may be withdrawn upondelivery of the device from the delivery catheter in order to allow thedevice to take its implantation shape. In another example, an inner wiremay be attached to the distal end of the tube, and the inner wire may bepulled relative to the tube to change the shape of the tube. Pulling theinner wire applies a compressive force to the tube. The tube may beformed with pre-shaped side cuts along the tube, such that it bends in apredetermined pattern, e.g., a spiral pattern, when such a load isapplied. A locking mechanism may be used to lock the wire in its loadedposition relative to the tube. Different depths and widths of the sidecuts and the distance between the side cuts would determine the finalshape of the tube element once a load is applied.

The device may have other elements to monitor the functioning of thedevice and the heart valve. For example, the device may be equipped witha sensor attached to the device. The sensor may be, for example, apressure sensor, a temperature sensor, and/or a velocity sensor. In thisway, the operation of the valve and the blood flow can be monitored.Similarly, the device itself when formed as a tube can be used as a “pigtail” for measuring pressure during or after the implantation procedure.

In one example of the use of sensors, the use of MEMS(microelectromechanical systems) sensors on the device may assist in theimplantation procedure or during the years after it. Such sensors maymonitor temperature, oxygen saturation, pressure, blood velocity orsimilar physical characteristics. During the implantation procedure, itis possible to use an xyz (positioning) sensor on the device to assistin the accurate location and positioning of the device by using anexternal system that reads the information transmitted from the sensor.

Sensor(s) on the device or delivery system may be part of a closed-loopsystem that uses the signals from the sensor(s) as feedback forautomatic delivery and positioning. By using pressure sensors in theventricle and atrium, the pressure can be continuously monitored as thedevice is automatically adjusted. The adjustments and monitoring can becontinued until target pressure readings are achieved. This automaticpositioning with the use of feedback can eliminate the need for manualmonitoring and positioning that can be complicated and less accurate.

The device may also have an energy-producing element that producesenergy by the flow of blood around the device and/or by the pressurechanges using a converter (such as piezoelectric element that is capableof converting mechanical pulse into electric current). The energy maycharge a battery that, for example, can be used to transmit signals fromone or more sensors as described above.

From the description herein, a person of ordinary skill in the art canrecognize that certain embodiments of devices and methods disclosedherein can have several advantages. For example, the device can safelyhold the chords without requiring grasping of the leaflets. The movementof the chords toward each other can be controlled by the structure ofthe device, including, for example, the number of turns of the spiral ofthe ventricular winding, the radii of those turns, and their shape.

Based on the above description and the accompanying drawings, theprinciples and operation of the invention, as well as how to make anduse the invention, can be understood by persons of ordinary skill in theart. Many embodiments and variations are possible that take advantage ofthe principles and operation of the invention described herein. Theexamples described herein and shown in the accompanying drawings aremeant as examples only and are not intended to be limiting of the scopeof the invention defined by the appended claims.

1. A device for assisting the functioning of a heart valve comprising: aventricular winding having a generally spiral shape adapted to bepositioned on a ventricular side of the heart valve such that chordsassociated with the heart valve are positioned within the path of thegenerally spiral shape of the ventricular winding; wherein the device isfree of any atrial stabilizing section.
 2. A device as in claim 1,wherein the ventricular winding is substantially flat.
 3. A device as inclaim 1, wherein the ventricular winding is substantially conical. 4-6.(canceled)
 7. A device as in claim 1, wherein the device is comprised atleast in part of a metallic material.
 8. A device as in claim 1, whereinthe device is comprised at least in part of a shape memory metalmaterial.
 9. A device as in claim 1, wherein the device is comprised atleast in part of nitinol.
 10. A device as in claim 1, wherein the deviceis comprised at least in part of a plastic material.
 11. A device as inclaim 1, wherein the device is comprised at least in part of a compositematerial. 12-13. (canceled)
 14. A device as in claim 1, wherein theventricular winding has an end portion that is angled downwardly.
 15. Amethod of repairing a heart valve comprising: delivering a heart valverepair device to the area of the heart valve, the heart valve repairdevice comprising a ventricular winding having a generally spiral shape;and positioning the ventricular winding on a ventricular side of theheart valve such that chords associated with the heart valve arepositioned within the path of the generally spiral shape of theventricular winding; wherein the heart valve repair device is free ofany atrial stabilizing section.
 16. A method as in claim 15, wherein thestep of positioning the ventricular winding comprises turning theventricular winding in a first direction such that the chords movecloser to the center of the ventricular winding.
 17. (canceled)
 18. Amethod as in claim 16, wherein the step of positioning the ventricularwinding comprises, after turning the ventricular winding in a firstdirection, turning the ventricular winding in a second direction suchthat the chords move further from the center of the ventricular winding,to adjust the positioning of the chords in the device.
 19. (canceled)20. A delivery system for implanting a heart valve repair device forrepairing a heart valve comprising: an applicator tube; and an internalrod within the applicator tube; wherein the internal rod is adapted tohold the heart valve repair device during maneuvering of the device; andwherein the delivery system is adapted to release the heart valve repairdevice by advancement of the internal rod relative to the applicatortube after positioning the heart valve repair device in the desiredlocation.
 21. A system for repairing a heart valve comprising: adelivery system comprising an applicator tube and an internal rod withinthe applicator tube to deliver a heart valve repair device to an area ofthe heart valve; and a heart valve repair device comprising aventricular winding that in an unconstrained condition has a generallyspiral shape, the heart valve repair device further comprising agrasping element that is connected to the center of the ventricularwinding and that extends from the center of the ventricular winding;wherein the heart valve repair device is adapted to be advanced to thearea of the heart valve with the ventricular winding held within theapplicator tube of the delivery device in a constrained condition inwhich the ventricular winding has a relatively straightened shape;wherein the ventricular winding is adapted to be released from theapplicator tube, thereby allowing the ventricular winding to assume itsunconstrained condition in which it has the generally spiral shape;wherein the ventricular winding is further adapted to be positioned onthe ventricular side of the heart valve and turned in a first directionsuch that the ventricular winding captures chords associated with afirst leaflet of the heart valve and chords associated with a secondleaflet of the heart valve within one generally spiral path defined bythe generally spiral shape of the ventricular winding, wherein byturning the ventricular winding in the first direction, the capturedchords of the first leaflet and the second leaflet within the generallyspiral path are brought toward the center of the ventricular winding,thereby causing the first leaflet and the second leaflet of the heartvalve to be drawn together; wherein the heart valve repair device isadapted to be released from the delivery system; and wherein the heartvalve repair device is free of any atrial stabilizing section.
 22. Thesystem as in claim 21, wherein in the unconstrained condition of theventricular winding, the generally spiral shape moves increasinglyfurther away from the center of the ventricular winding as it windsaround the center of the ventricular winding.
 23. The system as in claim21, wherein the generally spiral shape comprises at least a first turnand a second turn, wherein in a radial direction from a center of theventricular winding the second turn is farther away from the center ofthe ventricular winding than the first turn, and wherein at least thefirst turn is a full turn extending 360 degrees around a center of theventricular winding.
 24. The system as in claim 21, wherein the graspingelement has an axis, and wherein the ventricular winding is adapted tobe turned by using the delivery device to turn the grasping element,whereby turning the grasping element results in turning the ventricularwinding generally around the axis of the grasping element.
 25. Thesystem as in claim 21, wherein the heart valve repair device is adaptedsuch that after release from the delivery system, the heart valve repairdevice does not have any part that extends into an atrial side of thevalve.
 26. The system as in claim 21, wherein an overall diameter of theventricular winding is adapted to be smaller than a diameter of anannulus of the heart valve.
 27. The system as in claim 21, wherein theventricular winding is adapted to capture less than substantially all ofthe chords associated with the heart valve.